A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01014819

Acronym

Dermacorder

Enrollment

Registered

2009-11-17

Start date

2009-10-31

Completion date

2011-07-31

Last updated

2011-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basal Cell Carcinoma

Keywords

Dermacorder, Electric field, basal cell carcinoma, Gorlin Syndrome

Brief summary

The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.

Detailed description

The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. One previous clinical trial at the VA Medical Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their electric field. We have improved the Dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of Americans seeking the advice of dermatologists regarding suspicious lesions each year

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Study subjects must have had diagnosed at least one benign or malignant skin lesion; * Subject is from 18-75 years of age, inclusive; * Subject must sign and date all informed consent statements.

Exclusion criteria

* Subject is exhibiting signs of a bacterial or viral infection, including fever; * Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.

Countries

United States

Outcome results